By David Fairfield, Senior Vice President of Feed Services
The U.S. Food and Drug Administration (FDA) released draft guidance on Jan. 22 to assist facilities that are subject to the agency’s Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule develop an animal food safety plan. The draft guidance’s release corresponded with the Association of American Feed Control Officials (AAFCO) midyear meeting conducted Jan. 22-24 in Anaheim, Calif.
In remarks delivered at the AAFCO meeting, FDA stated the draft guidance represents the first five chapters of the overall guidance that the agency intends to release pertaining to the preventive controls requirements within the animal food rule. The five chapters provide an overview of:
- food safety plan requirements;
- recommendations for conducting a hazard analysis;
- hazards associated with the manufacturing, processing, packing, and holding of animal food;
- examples of preventive controls that may be used to significantly minimize or prevent animal food hazards; and
- preventive control management components.
FDA stated that the guidance is designed to cover the entire spectrum of facilities subject to the animal food preventive controls requirements, and, therefore, not all of its content will be applicable to all facilities. FDA also said it intends to publish additional guidance on the animal food preventive controls provisions and will continue to announce additional guidance as it becomes available. As an example, FDA noted that a future guidance document will provide in-depth guidance on the supply-chain program preventive control.
Businesses that are not classified as “small” or “very small” businesses under the rule were required to comply with the animal food preventive control provisions on Sept. 18, 2017. “Small” businesses need to comply by no later than Sept. 17, 2018, and “very small” businesses need to comply with limited provisions by Sept. 17, 2019. Last year, FDA announced that it intends to delay routine preventive controls inspections for large businesses until fall 2018 to allow the animal food industry more time to focus on development of their food safety plans and to consider information in the draft guidance.
FDA provided a comment period for the draft guidance that ends on July 23, 2018. The NGFA will be reviewing the draft guidance and submitting comments to the agency.
AAFCO is the professional organization of federal and state feed regulatory officials, with which the NGFA interacts extensively. Among other things, NGFA feed industry members and NGFA staff serve as non-voting advisers to key AAFCO committees and participated actively in committee discussions. Over 300 industry representatives and regulatory officials attended the Anaheim meeting.
Other Issues: Other significant issues addressed during the AAFCO meeting included:
- GRAS Ingredients: A workgroup within the AAFCO Ingredient Definition Committee currently is working to identify and pursue acceptable state alternatives to FDA’s review of independent generally recognized as safe (GRAS) conclusions. Existing federal law provides that independent GRAS determinations meeting federal standards are acceptable, and the workgroup is evaluating options that would facilitate state acceptance.
- List of Negative Ingredients: The Ingredient Definition Committee established a workgroup to evaluate whether to develop a list of substances that are not approved for use in animal food. The workgroup will offer its recommendations at a subsequent AAFCO meeting.
- Feed Labeling: The Feed Labeling Committee recommended the AAFCO Board of Directors consider the economics of developing a software program that could enable electronic review of feed labels. The AAFCO Board of Directors will consider the recommendation and potentially present the project to the AAFCO membership for approval. In addition, the committee assigned a workgroup to evaluate and make a recommendation as to whether maximum guarantees on tags of complete feeds should be required for certain potentially toxic mineral contaminants.
- Pet Food Issues: The Pet Food Committee had a significant discussion related to efforts to modernize pet food labels, as well as means to verify human grade claims made for pet food products. In addition, a 1-½ day pet food labeling workshop was held immediately after the AAFCO meeting.
- Feed Ingredient Definitions: Among the new definitions approved by the Ingredient Definitions Committee were: 1) oat fiber; 2) low glucosinolate high erucic acid rapeseed meal, solvent extracted; and 3) black soldier fly larvae meal. In addition, during committee discussion it was reiterated that hemp products currently have not been defined for use in animal food.
AAFCO will conduct its next meeting July 29 – Aug. 1, 2018 in Fort Lauderdale, Fla.